In vivo neurophysiological assessment of in silico predictions of neurotoxicity: Citronellal, 3,4-dichloro-1-butene, and benzyl bromoacetate

In vivo neurophysiological assessment of in silico predictions of neurotoxicity: Citronellal, 3,4-dichloro-1-butene, and benzyl bromoacetate

Authors: Jung GL, McDaniel KL, LoPachin RM, Geohagen BC, Smith A, Huffstickler M, Herr DW
Publication: Neurotoxicology
Keywords: animal testing, gastroplus, mechanistic absorption, pbk, PBPK modeling, pbtk, risk assessment, safety exposure, Toxicity
Software: GastroPlus®

Neurotoxicants may be widespread in the environment and can produce serious health impacts in the human population.

Clinical Pharmacokinetics and Pharmacodynamics of Esaxerenone, a Novel Mineralocorticoid Receptor Antagonist: A Review

Clinical Pharmacokinetics and Pharmacodynamics of Esaxerenone, a Novel Mineralocorticoid Receptor Antagonist: A Review

Authors: Janković SM, Jankovic SV
Publication: Eur J Drug Metab Pharmacokinet
Keywords: ddI, Drug-drug interactions, fih, first-in-human, gastroplus, gut metabolism, IVIVE, mechanistic absorption, PBPK modeling, physiologically based pharmacokinetics
Software: GastroPlus®

Esaxerenone is a selective, nonsteroidal, high-affinity mineralocorticoid receptor antagonist recently approved in Japan for the treatment of hypertension.

Potent Neutralization of Omicron and other SARS-CoV-2 Variants of Concern by Biparatopic Human VH Domains

Potent Neutralization of Omicron and other SARS-CoV-2 Variants of Concern by Biparatopic Human VH Domains

Authors: Chen C, Martinez DR, Marti MM, Schafer A, Cheng MH, Mannar D, Zhu X, Banerjee A, Sobolewski MD, Kim A, Treat BR, Castanha PMS, Enick N, McCormick KD, Liu X, Adams C, Hines MG, Sun Z, Chen W, Jacobs JL, Barratt-Boyes S, Mellors JW, Baric R, Bahar I, Dimitrov D, Subramaniam S, Saville J, Li W
Publication: bioRxiv
Keywords: biparatopic antibody, COVID-19, Omicron variant, SARS-CoV-2

The emergence of SARS-CoV-2 variants of concern (VOCs) requires the development of next-generation biologics that are effective against a variety of strains of the virus.

Post-Approval/Generics Track Poster Presentation: Use of PBBM to Establish Dissolution Safe Space via IVIVR for Concor®

Post-Approval/Generics Track Poster Presentation: Use of PBBM to Establish Dissolution Safe Space via IVIVR for Concor®

Authors: Macwan J
Conference: SLP MIDD+
Keywords: Concor, MIDD (model-informed drug development), MIDD+ 2022, modeling and simulation, pbbm, PBBM modeling, Post-Approval/Generics Track, SLP MIDD+ Virtual Conference, SLP2022MIDD
Division: PBPK

Presented by Joyce Macwan at SLP MIDD+ Virtual Conference February 16th-17th, 2022

Post-Approval/Generics Track Poster Presentation: Relationship between Pimavanserin Exposure and QTc Interval in Patients with Schizophrenia: Modelling Analysis from Randomized, Double-Blind, Placebo-Controlled Studies

Post-Approval/Generics Track Poster Presentation: Relationship between Pimavanserin Exposure and QTc Interval in Patients with Schizophrenia: Modelling Analysis from Randomized, Double-Blind, Placebo-Controlled Studies

Authors: Huang H
Conference: SLP MIDD+
Keywords: MIDD (model-informed drug development), MIDD+ 2022, modeling and simulation, pimavanserin, Placebo-Controlled Studies, Post-Approval/Generics Track, QTc, schizophrenia, SLP MIDD+ Virtual Conference, SLP2022MIDD
Division: PBPK

Presented by Hannah Huang at SLP MIDD+ Virtual Conference February 16th-17th, 2022

Post-Approval/Generics Track Poster Presentation: Therapeutic Drug Monitoring for Tyrosine Kinase Inhibitors. Possibilities, difficulties, and challenges

Post-Approval/Generics Track Poster Presentation: Therapeutic Drug Monitoring for Tyrosine Kinase Inhibitors. Possibilities, difficulties, and challenges

Authors: Chauvin J
Conference: SLP MIDD+
Keywords: MIDD (model-informed drug development), MIDD+ 2022, modeling and simulation, Post-Approval/Generics Track, SLP MIDD+ Virtual Conference, SLP2022MIDD, therapeutic drug monitoring, Tyrosine Kinase Inhibitors
Division: PBPK

Presented by Jonathan Chauvin at SLP MIDD+ Virtual Conference February 16th-17th, 2022

Clinical Track: Yo-Yo Dieting Predicted to Contribute to Fibrosis Score Reductions in Untreated (Placebo) Cohorts

Clinical Track: Yo-Yo Dieting Predicted to Contribute to Fibrosis Score Reductions in Untreated (Placebo) Cohorts

Authors: Shoda LKM
Conference: SLP MIDD+
Keywords: Clinical Track, MIDD (model-informed drug development), MIDD+ 2022, modeling and simulation, SLP MIDD+ Virtual Conference, SLP2022MIDDConference: SLP MIDD+, untreated cohorts, yo-yo dieting
Division: PBPK

Presented by Lisl Shoda at SLP MIDD+ Virtual Conference February 16th-17th, 2022

Post-Approval/Generics Track: Use of Exposure-Response Modeling to Support Regulatory Submission

Post-Approval/Generics Track: Use of Exposure-Response Modeling to Support Regulatory Submission

Authors: Passarell J
Conference: SLP MIDD+
Keywords: exposure-response models, MIDD (model-informed drug development), MIDD+ 2022, modeling and simulation, Post-Approval/Generics Track, regulatory submission, SLP MIDD+ Virtual Conference, SLP2022MIDD
Division: PBPK

Presented by Julie Passarell at SLP MIDD+ Virtual Conference February 16th-17th, 2022

Pre-Clinical Track: Advancing Calcitonin Gene Related Peptide Receptor Antagonists Using QST Modeling to Characterize Next-in-Class Compounds Compared to the Hepatotoxic First in Class Telcagepant

Pre-Clinical Track: Advancing Calcitonin Gene Related Peptide Receptor Antagonists Using QST Modeling to Characterize Next-in-Class Compounds Compared to the Hepatotoxic First in Class Telcagepant

Authors: Woodhead JL
Conference: SLP MIDD+
Keywords: Calcitonin, MIDD (model-informed drug development), MIDD+ 2022, modeling and simulation, Pre-Clinical Track, SLP MIDD+ Virtual Conference, SLP2022MIDD
Division: PBPK

Presented by Jeff Woodhead at SLP MIDD+ Virtual Conference February 16th-17th, 2022

Regulatory Roundtable: Development and validation of PBBM/safe space from the regulatory perspective, a panel discussion

Regulatory Roundtable: Development and validation of PBBM/safe space from the regulatory perspective, a panel discussion

Conference: SLP MIDD+
Keywords: MIDD (model-informed drug development), MIDD+ 2022, modeling and simulation, pbbm, PBBM modeling, SLP MIDD+ Virtual Conference, SLP2022MIDD, SLP2022MIDDConference: SLP MIDD+
Division: PBPK

This year we are happy to bring to you a hot topic suggested by last year's attendees. A regulatory roundtable on the Development and validation of PBBM and Safe Space from the regulatory perspective, is a one-hour panel discussion hosted by Sandra Suarez-Sharp and speakers from several regulatory agencies.

Pre-Clinical Track: Pushing the Boundaries Beyond – NextGen Session Panel Discussion and Live Q&A

Pre-Clinical Track: Pushing the Boundaries Beyond – NextGen Session Panel Discussion and Live Q&A

Authors: Clary J, Woodhead JL, Clemens L, Shoda LKM, Le Merdy M, Hamzavi N, Siler SQ
Conference: SLP MIDD+
Keywords: MIDD (model-informed drug development), MIDD+ 2022, modeling and simulation, Pre-Clinical Track, rspub, SLP MIDD+ Virtual Conference, SLP2022MIDD
Division: PBPK

Live Q&A with James Clary, Jeff Woodhead, Lara Clemens, Lisl Shoda, Maxime LeMerdy, Nader Hamzavi, Scott Q. Siler.

Discovery Track: Pushing the Boundaries Beyond – NextGen Session Panel Discussion and Live Q&A

Discovery Track: Pushing the Boundaries Beyond – NextGen Session Panel Discussion and Live Q&A

Authors: Miller D, Waldman M, Lawless M, Daga PR, Zin PP, Fraczkiewicz R
Conference: SLP MIDD+
Keywords: Discovery Track, MIDD (model-informed drug development), MIDD+ 2022, modeling and simulation, SLP MIDD+ Virtual Conference, SLP2022MIDD
Division: PBPK

Live Q&A with David Miller, Marvin Waldman, Michael Lawless, Pankaj R. Daga, Phyo Phyo Kyaw Zin, and Robert Fraczkiewicz.

Pre-Clinical Track Poster Presentation: Simulations using BIOLOGXsym demonstrate hepatotoxic potential of Tocilizumab through both on- and off-target effects

Pre-Clinical Track Poster Presentation: Simulations using BIOLOGXsym demonstrate hepatotoxic potential of Tocilizumab through both on- and off-target effects

Authors: Clemens L
Conference: SLP MIDD+
Keywords: BIOLOGXsym, MIDD (model-informed drug development), MIDD+ 2022, modeling, modeling and simulation, Pre-Clinical Track, simulations, SLP MIDD+ Virtual Conference, SLP2022MIDD, Tocilizumab
Division: PBPK

Presented by Lara Clemens at SLP MIDD+ Virtual Conference February 16th-17th, 2022